Evaluation of the Efficacy of High Doses of Methylprednisolone in SARS-CoV2 ( COVID-19) Pneumonia Patients

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This double blind, randomized study is aiming to evaluate the efficacy of three doses (1gr/day) of methylpredisolone added to standard therapy in patients, with documented COVID-19 pneumonia, requiring hospitalization but not mechanical ventilation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. age = 18 years;

2. Informed consent for participation in the study and for data processing;

3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;

4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);

5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;

6. PaO2 / FiO2 between 100 and 300 mmHg.

7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;

8. Serum CRP greater than 5 mg / dL;

9. Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days-

Exclusion Criteria:

1. Invasive mechanical ventilation;

2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;

3. Pregnancy or breastfeeding;

4. Severe heart or kidney failure;

5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;

6. Diabetes not compensated according to the doctor's judgment;

7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;

8. Steroid bolus therapy in the week prior to enrollment for the study;

9. Enrollment in another clinical trial;

10. Patient already randomized in this study-